Sterile article package and method of making the same



1965 R. M. GROSSMAN 3,203,545

STERILE ARTICLE PACKAGE AND METHOD OF MAKING THE SAME Filed Feb. 1, 1963 INVENTOR Robert M. Grossman AT TORNEYS United States Patent STERILE ARTICLE PA'CKAGE AND METHOD OF MAKING THE SAME Robert M. 'Grossman, Milledgeville, Ga, assignor to McGaw Laboratories, Inc Milledgeville, Ga., a corporation of Delaware Filed Feb. 1, 1 963, Ser. No. 255,610 '5 Claims. (CL 206-'63.2)

This invention relates to containers, and more particularly to a container for the sterilization and shipment, storage and ready access, under medically sterile conditions, of articles such as medical instruments or catheters.

Many articles used for medical and other purposes must be used in sterile condition in order to prevent contamination of the object with which the article is used. Typical of such articles of a medical nature are peritoneal dialysis catheters. They must be medically sterile when placed in the patient by the surgeon and are most convenient to use when they are packaged, shipped and stored in sterile condition and delivered in this condition to the sterile hands of the surgeon or sterile field of operation without the need for sterilization at the time of or just prior to use.

This invention permits sterile articles, such as peritoneal dialysis catheters, to be used in this convenient manner. It is a container in which the catheter is placed for sterilization and shipped and stored in sterile condition. Moreover, the invention permits the catheter to be removed by hands which are not sterile and yet be delivered to the sterile hands of a surgeon in sterile condition.

These and other features and advantages of the invention will be more clearly understood from the following detailed description and the accompanying drawings, in which like characters of reference designate corresponding parts in all figures, and in which:

FIG. 1 is a side elevation view of the container with a sterile catheter positioned within it.

FIG. 2 is an enlarged section view of the cap end of the container of FIG. 1 showing in detail the manner in which the cap grips the catheter and seals the container tube.

FIG. 3 is an enlarged section view of the cap end of the container of FIG. 1 showing the cap, container tube, and catheter after the catheter has been inserted into the cap but before the cap has been placed on the container tube.

FIGS. 4a-4e are a series of side elevation views showing a catheter and the assembly of the container with the sterile catheter within.

These drawings and the following detailed description disclose a preferred specific embodiment of the invention, but the invention is not limited to the details disclosed since it may be embodied in other equivalent forms.

This invention is best understood by considering the container to be comprised of a container tube 11 and a cap 12. The container tube 11 contains a catheter 13 or other similar articles within it. The cap 12 grips the catheter 13 when the catheter 13 is within the container tube 11 or is being withdrawn from or inserted into the container tube 11 and in addition closes and seals one end of the container tube 11 while at the same time permitting the passage of a sterilizing medium through the container tube 11 and around the catheter 13 and the convenient removal of the catheter 13 from the container tube 11 under sterile conditions. The container tube 11 is a cylindrical tube of plastic or some similar known material which will fuse to itself with the application of heat.

Initially, the container tube 11 is open at both ends 14 and 15 and preferably the material of which it is formed is transparent so that the catheter 13 or similar arcticle within it may be easily seen and identified.

The cap 12 is formed with a small cup 16 and a large 3,203,545 Patented Aug. 31, 1965 cup 17. The small cup 16 and large cup 17 are joined at their closed ends and have their centerlines coinciding. The outside diameter of the small cup 16 is less than the outside diameter of the large cup 17 and together the small cup 16 and large cup 17 form a hollow cylindrical tube having one end of larger diameter than the other end and a barrier 18 in its hollow interior.

The cap 12 is made of pliable, elastic material, such as rubber, and the inside diameter of the small cup 16 is slightly less than the outside diameter of one end 19 of the catheter 13 for which the container 10 is used. This inside diameter of the small cup 16 permits the end 19 of the catheter 13 to be slidably inserted into the small cup 16 and the end 19 of the catheter 13 to be firmly gripped by the elasticity of the small cup 16 asshown in FIG. 3.

The outside diameter of the large cup 17 increases slightly between closed end 20 and open end 21 and at the closed end 20 this outside diameter is substantially the same as the inside diameter of the container tube 11. This outside diameter of the large cup 17 at its closed end 20 permits the small cup 16, a catheter 13 being gripped by the small cup 16, and the closed end 20 of the large cup 17 to be easily inserted into the end 14 of the container tube 11. However, the cap 12 will not slide completely into the container tube 11 because the outside diameter of the large cup 17 at its open end 21 is sufiiciently greater than the inside diameter of the container tube 11 to prevent the open end 21 from sliding into the container tube 11.

The cap 12 permits a catheter 13 to be gripped by the cap 12 and placed in the container tube 11 with one end 19 positioned with reference to the end 14 of the container tube 11. The cap 12 and the inserted end 19 of the catheter 13 are fixedly positioned with reference to the end 14 of the container tube 11 by turning the large cup 17 back along itself from open end 21 toward closed end 20. This turns the large cup 17 inside out so that it encircles the end 14 of the container tube 11 as shown in FIG. 2. The inverting of the large cup 17 is facilitated by the fact that the open end 21 has a greater outside diameter than the closed end 20. The elasticity of the large cup 17 insures that the cap 12 is firmly, but removably, attached to the end 14 of the container tube 11. In this position, the cap 12 seals the end 14 of the container tube 11 and at the same time firmly fixes the position within the container tube 11 of a catheter 13 having one end 19 inserted into the small cup 16. This gripping of the catheter 13 within the container tube 11 prevents damage to catheter 13 when the container tube 11 is shipped or handled.

The small cup 16 and catheter 13 are positioned in the container tube 11 and the end 14 of the container tube 11 is sealed by inverting the large cup 17 while the end 15 of the container tube 11 is still open. The open end 15 permits the catheter 13 to be sterilized after it has been positioned within the container tube 11 by simply introducing a sterilizing medium through the open end 15 of the container tube 11. Although many of the known sterilizing mediums may be used, it has been found that a mixture of ethylene oxide and carbon dioxide produces good results. The sterilizing medium is introduced into the open end 15 of the container tube 11 under suflicient pressure to cause the medium to pass the length of the container tube 11 and between the inverted cap 12 and the container tube 11 as illustrated in FIG. 4d. As a result, the catheter 13, the interior surface of the container tube 11, the edge 22 of the end 14 of the container tube 11, and the overlapping surfaces of the container tube 11 and the large cup 17 are sterilized by the sterilizing medium.

The container 10 is sealed for shipment and storage by closing the open end 15 of the container tube 11 with the sterilizing medium still within the container tube 11. This is accomplished by using one of the many known methods of fusing plastic or similar materials, and is most easily accomplished by simply squeezing that portion of the length of the container tube 11 into which the catheter 13 does not extend between two hot irons of known type. The mechanical pressure of the irons will flatten the container tube 11 into a fan-shaped edge 23 fused into a single mass by the heat of the irons.

Although the elasticity of the cap 12 will permit the sterilizing medium under pressure to pass out of the end 14 of the container tube 11 between the cap 12 and container tube 11, it will prevent air or other contaminating material from entering the container tube 11 after end 15 has been sealed. However, to insure that cap 12 completely seals end 14 of the container tube 11 and remains firmly positioned on the container tube 11, a sealing ring 24 is placed around the cap 12 and that portion 25 of the container tube 11 immediately below the cap 12.

The sealing ring 24 is of known type, being of material which shrinks as it dries from a wet condition. The sealing ring 24 is placed in position over the cap 12 and container tube 11 when wet "and when it dries, it squeezes the cap 12 against the container tube 11 and firmly holds the cap 12 in position with reference to that portion 25 of the container tube 11 below the cap 12 which it is also squeezing. The sealing ring 24 makes the container 10 tamper-proof and further insures that the catheter 13 will be kept completely sterile during shipment and storage in the container 10.

The container 10 not only permits a catheter 13 or similar article to be sterilized after being placed within the container tube 11, and a catheter 13 to be shipped or stored in sterile condition, but it also permits a catheter 13 to be conveniently removed from the container 10 by unsterile hands and delivered in sterile condition to the sterile hands of a surgeon or a sterile field of operation. The sealing ring 24 has perforations 26 just below the inverted edge 27 of the large cup 17 and removal of the catheter 13 from the container tube 11 is accomplished simply by breaking the sealing ring 24 along the perforations, by grasping the inverted large cup 17 and pulling it from the end 14 of the container tube 11, and by withdrawing the catheter 13 from the container tube 11 with the cap 12. The hands of the person removing the catheter 13 from the container 10 touch only the cap 12 and do not touch the catheter 13 or that sterile portion of the container tube 11 previously enclosed by the large cup 17 of the cap 12. Thus, there is no danger of the sterile catheter 13 being contaminated by direct contact with hands or by striking a contaminated portion of the container tube 11 as the catheter 13 is withdrawn from the container 10.

The gripping of an end 19 of catheter 13 by the small cup 16 not only permits the catheter 13 to be removed from the container 10 by the cap 12, but it also permits the catheter 13 to be carried by the cap 12 after its removal from the container 10 and to be delivered to a surgeon or placed in a field of operation where sterile hands or other means can be used to pull the end 19 of the catheter 13 from the cap 12 held by unsterile hands. Thus, the catheter 13 is delivered in completely sterile condition to a surgeon or field of operation without sterilization at the time of or just prior to use.

It will be obvious to those skilled in the art that many variations may be made in the embodiments here chosen for the purpose of illustrating the present invention without departing from the scope thereof as defined in the appended claims.

What is claimed as invention is:

1. A method for packaging sterile articles comprising the steps of placing the article within a container open at both ends, resiliently closing one end of the container, introducing a sterilizing gas into the still open end of the container under suflicient pressure to force the gas through the container and out the resiliently closed end, and sealing the still open end of the container.

2. A method of packaging sterile articles comprising the steps of placing the article within a container open at both ends, resiliently closing one end of the container, introducing a mixture of ethylene oxide and carbon dioxide gas into the still open end of the container under sufiicient pressure to force the gas through the container and out the resiliently closed end, and sealing the still open end of the container.

3. A method for packaging sterile articles comprising the steps of inserting the article within a recess provided in a resilient closing means, inserting the article within a container open at both ends by insertion of the resilient closing means in one end of the container, introducing sterilizing gas into the still open end of the container under suflicient pressure to force the gas through the container and out the resiliently closed end, and sealing the still open end of the container.

' 4. A method for packaging sterile articles comprising the steps of inserting the article within a recess provided in a resilient closing means, placing the article within a container open at both ends by closing one end of the container with the resilient closing means, introducing a mixture of ethylene oxide and carbon dioxide into the still open end of the container under sufficient pressure to force the gas through the container and out the resiliently closed end, and sealing the still open end of the container by heat.

5. In combination a flexible reversible cap and a container tube for a sterile catheter having a cylindrical open end, said cap including a body portion having formed therein an inwardly directed small elastic retaining cup having a centerline, and an outside diameter less than the inside diameter of the container tube, said cup having the end of a catheter inserted therein, said retaining cup and catheter being positioned within the cylindrical open end of the container tube, and a large flexible and reversible substantially cylindrical cup formed integral with said body portion and extending axially outwardly therefrom, said large cup having a centerline which coincides with the centerline of the small cup, an outside diameter near its bottom which is substantially the same as the inside diameter of the container tube, and an outside diameter at its open end which is greater than the inside diameter of the container tube, as the body portion is inserted into the open end of the container tube, the flexibility of the material of the larger cup and the internal diameter of said cup relative to the external diameter of the container tube is such as to permit the inversion of said cup over the outside of said container tube to resiliently close said open end against ingress of ambient air under atmospheric pressure and to permit sterilization of the catheter in said container tube by the passage of a sterilizing gas under pressure exceeding atmospheric through said container tube and out the resiliently closed end.

References Cited by the Examiner UNITED STATES PATENTS 1,050,043 1/13 Sellar 206-43 2,261,875 11/41 Dunn 215-38 2,302,933 11/42 Barol 206-632 2,634,856 4/53 Perkins 206-632 2,953,243 9/60 Roehr 206-43 2,954,139 9/60 Owens 215-38 3,074,578 6/63 Hester 215-41 3,107,785 10/63 Roehr 206-43 3,112,747 12/63 Cowley 206-43 THERON E. CONDON, Primary Examiner. GEORGE O. RALSTON, Examiner. 

5. IN COMBINATION A FLEXIBLE REVERSIBLE CAP AND A CONTAINER TUBE FOR A STERILE CATHETER HAVING A CYLINDRICAL OPEN END, SAID CAP INCLUDING A BODY PORTION HAVING FORMED THEREIN AN INWARDLY DIRECTED SMALL ELASTIC RETAINING CUP HAVING A CENTERLINE, AND AN OUTSIDE DIAMETER LESS THAN THE INSIDE DIAMETER OF THE CONTAINER TUBE, SAID CUP HAVING THE END OF A CATHETER INSERTED THEREIN, SAID RETAINING CUP AND CATHETER BEING POSITIONED WITHIN THE CYLINDRICAL OPEN END OF THE CONTAINER TUBE, AND A LARGE FLEXIBLE AND REVERSIBLE SUBSTANTIALLY CYLINDRICAL CUP FORMED INTEGRAL WITH SAID BODY PORTION AND EXTENDING AXIALLY OUTWARDLY THEREFROM, SAID LARGE CUP HAVING A CENTERLINE WHICH COINCIDES WITH THE CENTERLINE OF THE SMALL CUP, AN OUTSIDE DIAMETER NEAR ITS BOTTOM WHICH IS SUBSTANTIALLY THE SAME AS THE INSIDE DIAMETER OF THE CONTAINER TUBE, AND AN OUTSIDE DIAMETER AT ITS OPEN END WHICH IS GREATER THAN THE INSIDE DIAMETER OF THE CONTAINER TUBE, AS THE BODY PORTION IS INSERTED INTO THE OPEN END OF THE CONTAINER TUBE, THE FLEXIBILITY OF THE MATERIAL OF THE LARGE CUP AND THE INTERNAL DIAMETER OF SAID CUP RELATIVE TO THE EXTERNAL DIAMETER OF THE CONTAINER TUBE IS SUCH AS TO PERMIT THE INVERSION OF SAID CUP OVER THE OUTSIDE OF SAID CONTAINER TUBE TO RESILIENT CLOSE SAID OPEN END AGAINST INGRESS OF AMBIENT AIR UNDER ATMOSPHERIC PRESSURE AND TO PERMIT STERILIZATION OF THE CATHETER IN SAID CONTAINER TUBE BY THE PASSAGE OF A STERILIZING GAS UNDER PRESSURE EXCEEDING ATMOSPHERIC THROUGH SAID CONTAINER TUBE AND OUT THE RESILIENTLY CLOSED END. 